Business Wire

Data at EAHAD 2021 Highlight Value of Takeda’s Leading Hematology Portfolio in Clinical Settings and Commitment to Patient-Focused Advancements

Share

Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE:TAK) (“Takeda”) today announced that 14 abstracts from the company’s Hematology portfolio and pipeline are being presented as electronic posters at the Virtual European Association for Haemophilia and Allied Disorders Congress (EAHAD 2021). Data include multiple abstracts reinforcing the long-term efficacy and safety of Takeda’s hematology portfolio in clinical practice, supporting the value of these treatments in a real world setting.

Seven year AHEAD study data [ABS034] showed that prophylactic antihemophilic factor (recombinant), rAHF (ADVATE), achieved lower annualized bleeding rates (ABRs) and annualized joint bleeding rates (AJBRs) than on-demand treatment in all patients with severe hemophilia A. Key outcomes included ABRs (all bleeds), AJBRs, joint health (evaluated by Gilbert score), and adverse events (AEs). AEs occurred in 414/702 (59.0%) patients (serious AEs in 141/702). 12 patients developed de novo FVIII inhibitors (high titer [>5 BU], n=2 [transient]; low titer [≤5 BU], n=10 [1 transient, 9 persistent].1 A separate analysis of patients with moderate or severe hemophilia A and target joints [ABS170] showed that prophylactic rAHF maintained lower bleed rates than on-demand treatment over seven years.2

A further retrospective study [ABS039] investigated the impact of switching patients with moderate or severe hemophilia A in US clinical practice (without inhibitors) from Factor VIII prophylaxis to rurioctocog alfa pegol (ADYNOVATE) or emicizumab. Results showed that there were no statistically significant differences in prophylactic effectiveness between treatments.3

“For rare diseases such as hemophilia, gathering evidence from clinical practice is crucial to advance treatment and reduce gaps in patient care,” commented Professor Margareth Ozelo, Director of the WFH International Haemophilia Training Centre, University of Campinas, Brazil. “These data add to the body of evidence for the management of hemophilia, and reinforce the value of using evidence from real world settings to personalized care, improve patient outcomes, and address the unique needs of every single patient.”

Additional abstracts presented at EAHAD 2021 further reinforce the efficacy and safety of Takeda’s portfolio for both on-demand and prophylaxis treatment in real world settings [ABS093, ABS113, ABS181, ABS070, ABS112],illustrate the benefit of PK-guided, personalized prophylaxis to help support patient outcomes in hemophilia [ABS120, ABS190], and demonstrate our ongoing commitment to innovation in hematology [ABS185].

###

About Hemophilia
Hemophilia is a chronic disease that causes longer-than-normal bleeding due to absent or deficient clotting factor in the blood.4 Hemophilia A is more common than hemophilia B; in 2018, hemophilia A affects about 173,711 people, whereas hemophilia B affects about 34,289 people worldwide.5

People with hemophilia, working closely with their healthcare professionals, can live healthy lives with proper care and adequate treatment.6 Treatment regimens typically include on-demand and/or regular prophylactic infusions of factor replacement therapy to control or prevent the risk of bleeding.7

About Takeda Hematology
Following its recent acquisition of Shire, Takeda is a leader in hemophilia with the longest heritage and market-leading portfolio, backed by established safety and efficacy profiles with decades of real-world experience. We have 70+ years driving innovation for patients8 and a broad portfolio of 11 products across multiple bleeding disorders.9 Our experience as leaders in hematology means we are well prepared to meet today’s needs as we pursue future developments in the care of bleeding disorders. Together with the hematology community, we are raising expectations for the future, including earlier diagnosis, earlier and full protection against bleeds, and more personalized patient care.

E.U. Indication and Important Safety Information
About
ADVATE (human coagulation factor VIII (rDNA), octocog alfa)
Please consult the ADVATE Summary of Product Characteristics (SmPC) before prescribing, particularly in relation to dosing and treatment monitoring (here).

Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in the SmPC or to mouse or hamster proteins.

Special warnings and precautions for use
The product contains traces of mouse and hamster proteins. If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the product immediately and contact their physician.

Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis.

The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII procoagulant activity, which are quantified in Bethesda Units (BU) per mL of plasma using the modified assay.

In general, all patients treated with coagulation factor VIII products should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests. If the expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, testing for factor VIII inhibitor presence should be performed.

After reconstitution this medicinal product contains 0.45 mmol sodium (10 mg) per vial.

Adverse Reactions

Very common (≥1/10)

Factor VIII inhibition in previously untreated patients (PUPs)

Common

(≥1/100 to <1/10)

Headache, Pyrexia

Uncommon

(≥1/1000 to <1/100)

Influenza, Laryngitis, Factor VIII inhibition in previously treated patients (PTPs), Lymphangitis, Dizziness, Dysgeusia, Memory impairment, Migraine, Syncope, Tremor, Eye inflammation, Palpitations, Haematoma, Hot flush, Pallor, Dyspnoea, Abdominal pain upper, Diarrhoea, Nausea, Vomiting, Hyperhidrosis, Pruritus, Rash, Urticaria, Chest discomfort, Chest pain, Chills, Feeling abnormal, Peripheral oedema, Vessel puncture site haematoma, Coagulation factor VIII level decreased, Haematocrit decreased, Laboratory test abnormal, Monocyte Count increased, Post procedural complication, Post procedural haemorrhage, Procedural site reaction

Not known

Anaphylactic reaction, Hypersensitivity, Fatigue, Injection site reaction, Malaise

For the ADVATE US Prescribing Information, please refer here.

About ADYNOVATE/ADYNOVI®▼ (Pegylated human coagulation factor VIII (rDNA), rurioctocog alfa pegol)
Detailed Safety Information
Please consult the ADYNOVI Summary of Product Characteristics (SmPC) before prescribing, particularly in relation to dosing and treatment monitoring (here)

Contraindications
Hypersensitivity to the active substance, to the parent molecule octocog alfa or to any of the excipients listed in the SmPC. Known allergic reaction to mouse or hamster protein.

Special warnings and precautions for use
The medicinal product contains traces of mouse and hamster proteins. If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the medicinal product immediately and contact their physician. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.

The formation of neutralising antibodies (inhibitors) against factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII procoagulant activity, which are quantified in Bethesda Units (BU) per mL of plasma using the modified assay.

In general, all patients treated with coagulation factor VIII should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests. If the expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, testing for factor VIII inhibitor presence should be performed.

After reconstitution this medicinal product contains 0.45 mmol sodium (10 mg) per vial.

Adverse Reactions

Common

(≥1/100 to <1/10)

Headache, Diarrhoea, Nausea, Rash

Uncommon

(≥1/1000 to <1/100)

Factor VIII inhibition in previously-treated patients (PTPs), Hypersensitivity, Flushing

For the ADYNOVATE US Prescribing Information, please refer here.

About Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Diseases, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries.

For more information, visit https://www.takeda.com.

Important Notice
For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

Forward-Looking Statements
This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could” “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations; the success of or failure of product development programs; decisions of regulatory authorities and the timing thereof; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/reports/sec-filings/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

Medical information
This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

###


1 EAHAD 2021. Abstract ABS034. 7 Interim Analysis of Antihemophilic Factor (recombinant) and Joint Health in Patients with Hemophilia A: AHEAD International.
2 EAHAD 2021. Abstract ABS170. Real world Bleeding Rates over 7 Years of Antihemophilic Factor (recombinant) in Patients with Hemophilia A and Target Joints: AHEAD International
3 EAHAD 2021. Abstract ABS039. A Retrospective Study of the Impact of Switching Patients with Haemophilia A to rurioctocog alfa pegol or emicizumab in US Practice.
4 World Federation of Hemophilia. Introduction to hemophilia: what is hemophilia?. World Federation of Hemophilia website. Available at: https://bit.ly/356zUDQ. Last accessed January 2021.
5 20 Anniversary Report on the Annual Global Survey 2018. World Federation of Hemophilia. Available at: https://bit.ly/3hGDUzU. Last accessed January 2021.
6 World Federation of Hemophilia. “Introduction to hemophilia: treatment.” Available here: https://bit.ly/3b7Pfry. Last accessed January 2021.
7 NHS. Haemophilia: treatment. Available here: https://bit.ly/3oqhAwY. Last accessed January 2021.
8 Takeda Website. Rare Diseases. Available at: https://bit.ly/3n9gvIN. Last accessed January 2021.
9 Takeda Website. U.S. Product List. Available at: https://bit.ly/35a6HYF. Last accessed January 2021.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Media Contacts:

Japanese Media
Kazumi Kobayashi
kazumi.kobayashi@takeda.com
+81 (0) 3-3278-2095

Media outside Japan
Emily Bunting
emily.bunting@takeda.com
+41 79 866 97 03

About Business Wire

Business Wire
Business Wire



Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Pricefx Named a Finalist for 2021 SAP ® Pinnacle Award in the Partner of Year – Endorsed Apps Category18.5.2021 15:30:00 CEST | Press release

Pricefx, the global leader in cloud-native pricing software, today announced that it has been recognized by SAP as a finalist for a 2021 SAP® Pinnacle Award in the Partner of the Year – Endorsed Apps category. This award recognizes an SAP partner that has created a world-class SAP endorsed app that complements SAP technologies and has contributed a significant amount of value to SAP and its end customers. Last year, Pricefx was a finalist for SAP App Center Partner of the Year. The annual SAP Pinnacle Awards acknowledge the contributions of leading SAP partners that have excelled in developing and growing their partnership with SAP and helping customers meet their goals. Finalists and winners in 28 categories were chosen based on recommendations from SAP, customer feedback and performance indicators. SAP Endorsed Apps are premium certified by SAP with added security, in-depth testing and measurements against benchmarks results. A leader in price optimization, Pricefx’s SAP endorsed app

Andersen Global Broadens Coverage in Liechtenstein and Switzerland18.5.2021 15:30:00 CEST | Press release

Andersen Global adds legal capabilities in Liechtenstein and Switzerland through a Collaboration Agreement with NSF, strengthening the organization’s platform as it continues its expansion in the region. With offices in Vaduz and Zurich, NSF operates with five Partners and 40 professionals, serving individuals and international corporations. The full-service location in Liechtenstein provides a range of services in legal, trust and asset management with capabilities in banking and capital markets, tax, corporate, M&A, arbitration and dispute resolution, contracts, and administrative and constitutional law. Additionally, the office in Switzerland operates as an independent Swiss law firm and offers services in various areas of business law, such as criminal tax law, corporate/M&A, succession planning, inheritance law, litigation, restructuring, debt enforcement and insolvency, employment, financial markets as well as commercial contracts. “For more than 30 years, our extensive experienc

Heise Medien relies on the Xpublisher editorial system18.5.2021 15:04:00 CEST | Press release

Heise Medien GmbH & Co. KG, one of Germany’s leading tech industry publishers, succeeded in establishing transparent and well-organized content and media asset management together with a highly streamlined production process for its magazines by implementing Xpublisher. Xpublisher supports content utilization along the entire value chain, from planning, editorial creation, editing, and layout to the final publication, based on a “content first” approach. This enables Heise Medien to publish across multiple channels in a way that is highly efficient, cost effective, and error free. "We are pleased that Heise Medien trusts in our expertise and successfully automates their magazine production with our editorial system", says Matthias Kraus, CEO of Xpublisher. The numbers are a testament to the project’s success: Instead of the typical production phase of ten days, the first issue of c't was ready for printing in just nine days. In digital production, the company succeeded in both enhancin

Thales Announces New Solutions to Help Organisations Discover, Protect and Control Sensitive Data in Multicloud Environments18.5.2021 15:00:00 CEST | Press release

Thales today announced new data protection solutions for Google Cloud, Microsoft Azure, and Amazon Web Services, solidifying its role as a trusted third party for multicloud data security. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210518005282/en/ © Thales With each cloud provider having unique data protection mechanisms and key management offerings, multicloud data protection presents a complex security challenge for organisations. Thales’ latest cloud data security solutions allow customers to maintain control of and manage their encryption keys, as well as manage access and authentication across hybrid and multicloud environments. “These capabilities are critical to cloud migration and security, especially with such accelerated growth in this area,” said Sunil Potti, Vice President and General Manager of Google Cloud Security. “True to our mission, we have forged this collaboration with Thales to further protect our

Trialbee Extends Executive Team and Launches Partner Program to Accelerate Growth, Expand Global Reach18.5.2021 15:00:00 CEST | Press release

Trialbee, a patient matching and enrollment platform, today announces key additions to its leadership team and a strategic partner program to further accelerate the company’s growth. These additions come during a period of unprecedented business results and will further scale the company’s global patient recruitment capabilities for clinical trials. Trialbee’s emergence as a trusted partner comes at a time when finding qualified patients and simplifying their journey into clinical research is more important than ever. Trialbee Hive™ utilizes real-world data (RWD) and advanced data science to model and expand patient targeting, providing greater awareness, inclusivity, and diversity of relevant patient populations. Interested patients are then engaged through Trialbee’s Candidate Manager platform that incorporates live nurse qualification and telehealth capabilities to refer study-ready patients into the trial, reducing site burden and enhancing enrollment outcomes. Four of the world’s

Styra Raises $40 Million in Series B Funding to Drive Access, Security and Compliance in Cloud-Native Applications18.5.2021 14:59:00 CEST | Press release

Styra, Inc., the founder of Open Policy Agent (OPA) and leader in cloud-native authorization, has raised a $40 million Series B funding round to continue driving the reinvention of policy and authorization for cloud-native applications. The round was led by Battery Ventures with participation from previous investors, A. Capital, Unusual Ventures, and Accel, as well as new investors at Capital One Ventures and Citi Ventures. With this funding, Dharmesh Thakker, General Partner at Battery Ventures, will be joining the Styra board. The round further solidifies its market leadership and provides capital to accelerate its founders’ vision—to create the standard for authorization—which started with OPA. OPA, initially proven out at scale by the likes of Netflix, Capital One, Atlassian, Pinterest and others, has now reached the point of over one million downloads per week. Styra has also seen exponential business traction in 2020, achieving 300% customer and commercial growth year-over-year,

Philip Morris International Reports Progress Toward Accelerating the End of Smoking18.5.2021 14:23:00 CEST | Press release

Philip Morris International Inc. (PMI) (NYSE: PM) today published its Integrated Report, a comprehensive overview of the company’s environmental, social, and governance (ESG) performance and its progress toward its purpose of delivering a smoke-free future. This includes its 2025 ambitions to have switched more than 40 million adult smokers to its smoke-free products, with half from non-OECD countries, and for smoke-free products to account for more than 50 percent of PMI’s total net revenues. Further accelerating PMI’s transformation, this year the company introduced two new 2025 ambitions, linked to its Business Transformation Metrics: for its smoke-free products to be available in 100 markets and for at least USD 1 billion in annual net revenues to come from “beyond nicotine” products. The Integrated Report also outlines case studies of early indications of PMI’s smoke-free products’ impacts in markets where such products have a meaningful presence. “I present this report with pride

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom